A Phase 4 interventional study of Parecoxib and Placebo in Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Completed at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-02-19.
Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Phase 4, Interventional, and Prevention
This prospective, double blind, placebo-controlled, parallel group study will be conducted in the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged 18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia will be involved in this study. According to previous studies and our pilot trial, estimated 120 patients will be involved in this study. All eligible patients will be randomly assigned to two groups. In group P, patients will receive parecoxib 40mg intravenously 30min before intubation, 8h and 20h after the surgery,respectively. In Group C, patients will receive normal saline at the same time points. The shoulder pressure pain thresholds will be measured with a pressure algometer by an independent doctor blinding to medication and grouping at the day before surgery, 24h and 48h after surgery. Moreover, the intensity of shoulder pain and side effects will be evaluated by another independent doctor at 24h and 48h after surgery. At the end of the observation, the intensity of the maximal shoulder pain will be assessed.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 140 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.
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Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery.
Drug: Parecoxib
Normal saline 5ml will be intravenously infused at the same time points., respectively.
Drug: Placebo
Parecoxib 40mg will be intravenously infused.
Normal saline 5ml will be intravenously infused.
The change of shoulder pressure pain threshold
The patients keep sitting position, and the pressure pain thresholds are measured twice at a fixed point in bilateral levator scapulae, supraspinatus, pectoralis major and flexor carpi ulnaris with a pressure algometer (FPX25, Wagner Instruments, USA) by an independent doctor.
Time frame: The pressure pain thresholds are measured at the day before surgery, 24h and 48h after surgery
The severity of shoulder pain
The patients are asked to rate the severity of shoulder pain via a visual analog scale (VAS) ranging from no pain (0) to worst possible pain (10) by another independent doctor.
Time frame: At the day before surgery, 24h and 48h after surgery
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital, Sun Yat-Sen University